FDA.reportPublic FDA data

BIOER Viral Transport Medium

Primary DI
06973843228297
Brand
BIOER Viral Transport Medium
Company
Hangzhou Bioer Technology Co., Ltd.
Model
BSC85X1-A1
Device description
For the detail information, please refer to the IFU.
Published
2023-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973843228297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973843228297069738432282976973843228297

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Regulatory Flags#

DUNS number
545256935
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973843220277BIOER GeneExplorer Thermal CyclerGE-96G2023-01-11
06973843220376BIOER GeneExplorer Thermal CyclerGE-48DS2023-01-11
06973843220383BIOER GeneExplorer Thermal CyclerGE-384G2023-01-11
06973843220390BIOER GeneExplorer Thermal CyclerGE-4I2023-01-11
06973843220420BIOER GeneExplorer Thermal CyclerGE-48D2023-01-11
06973843220482BIOER GeneExplorer Thermal CyclerGE-96S2023-01-11
06973843220499BIOER GeneExplorer Thermal CyclerGE-48DG2023-01-11
06973843220505BIOER LineGene MiniS Fluorescent Quantitative Detection SystemFQD-16B(EA2)2023-01-11
06973843220512BIOER LineGene MiniS Fluorescent Quantitative Detection SystemFQD-16B(EA4)2023-01-11
06973843220529BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA2)2023-01-11
06973843220536BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA4)2023-01-11
06973843220543BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA5)2023-01-11
06973843220550BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA6)2023-01-11
06973843220567BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA4)2023-01-11
06973843220574BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA5)2023-01-11
06973843220581BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA6)2023-01-11
06973843220802careSTART™ Q1 AmplifierTQA-E001822025-02-11
06973843220864GenePure Pro 16H Nucleic Acid Purification SystemNPA-16H2025-02-11
06973843220871Thermo Cell Mixing Block MB-1012025-02-11
06973843220888Thermo Shaker Mixing Block MB-2022025-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973471962171BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962188BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962195BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962201BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962218BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962225BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962232BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962249BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962256BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962263BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
00810164510815Atida Viral Transport Medium (Non-inactivated Type)ACESO LABORATORIES INC.JSM2026-03-23
38053326011826BD FCTCOPAN ITALIA SPAJSM2026-01-26
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011710UriSponge™COPAN ITALIA SPAJSM2025-03-12
38053326011598UTM®COPAN ITALIA SPAJSM2024-11-13
38053326011604UTM® COPAN ITALIA SPAJSM2024-11-13
38053326011611UTM® COPAN ITALIA SPAJSM2024-11-13
00816576026067TransPROHARDY DIAGNOSTICSJSM2024-10-08
16977644780029BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780036BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780043BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780012BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-12
16973471969941BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23
16973471969996BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23